everX Flow
510(k) K192260
everX Flow is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Gc America Inc., cleared under FDA 510(k) K192260 on 22 Nov 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192260 | Date22 Nov 2019 | StatusActive |
Official records
- FDA 510(k) database K192260
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192260
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| everX Flow 012898 | 012898 / 012898 | D0470128981 | — | On the market |
| everX Flow 012899 | 012899 / 012899 | D0470128991 | — | On the market |
| EverX Flow 012899 | 012899 / 012899 | 14548161292788 | — | On the market |
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